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A Single-center, Randomized, Double-blind, Active- and Placebo Controlled, 5-way Crossover Study Assessing the Abuse Potential of Intranasally Administered VYCAVERT Tablets in Non-dependent Recreational Opioid Users

Trial Profile

A Single-center, Randomized, Double-blind, Active- and Placebo Controlled, 5-way Crossover Study Assessing the Abuse Potential of Intranasally Administered VYCAVERT Tablets in Non-dependent Recreational Opioid Users

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 May 2019

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At a glance

  • Drugs Hydrocodone/paracetamol (Primary) ; Hydrocodone; Paracetamol
  • Indications Pain
  • Focus Pharmacodynamics; Registrational
  • Sponsors Acura Pharmaceuticals
  • Most Recent Events

    • 26 Aug 2013 Primary endpoint 'Drug cravings' (subject like/dislike scores) has not been met according to an Acura Pharmaceuticals media release.
    • 26 Aug 2013 Primary endpoint 'Drug-cravings' has not been met.
    • 26 Aug 2013 Acura Pharmaceuticals will further evaluate trial results with plans to meet with the US FDA for discussion. The NDA submission will likely be delayed as a consequence of failure to demonstrate statistical significance for the primary endpoint.
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